510(k) Report

FDA applicant

Novamedix, Ltd.

Washington, DC3 decisions1992–19962 recalls

FDA records 3 decisions for Novamedix, Ltd. (Washington, DC) from 1992 to 1996: 3 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Novamedix, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novamedix, Ltd. since 2007.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Novamedix, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOWSleeve, Limb, Compressible3decisions

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K953648A-V Impulse System Model 6060Novamedix, Ltd. · 19964cite it
  • K951683A-V Impulse System Model 6060Novamedix, Ltd. · 19952cite it
  • K914461A-V Impulse SystemNovamedix, Ltd. · 19921cites it

What has FDA decided for it lately?

  • K953648A-V Impulse System Model 6060Novamedix, Ltd. · 1996
  • K951683A-V Impulse System Model 6060Novamedix, Ltd. · 19952 recalls
  • K914461A-V Impulse SystemNovamedix, Ltd. · 1992

All 3 as Novamedix, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K951683AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066Aug 11, 2010
  • K951683AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067Aug 11, 2010